The present invention relates to the treatment of anorectal diseases including hemorrhoids by the application of novel pharmaceutical compositions containing a unique agent possessing wound-healing and antimicrobial properties.
There are currently a number of compositions for treatment of anorectal diseases including hemorrhoids. Some of them are based on anesthetic (U.S. Pat. No. 4,118,480) or vasoconstrictive (U.S. Pat. Nos. 3,608,074; 4,145,441; 4,383,986) properties of active agents and are used only to give temporary symptomatic relief. Others, whose mechanism of activity is unknown, have been limited to external application (U.S. Pat. Nos. 3,950,540; 3,950,541).
In contrast to compositions used for temporary relief, sustained symptomatic relief can be achieved by treating anorectal diseases including hemorrhoids with preparations containing wound-healing agents. Anorectal diseases are often initiated by the breakdown of epithelium, dermis, and other subcutaneous tissues which may result in a variety of wounds including fissures, cracks, abscesses, and hemorrhoids. But even when tissues still remain intact, as it is sometimes the case for certain types of hemorrhoids, they are considered as wounds because inflammation occurs. Inflammation of tissues is associated with many symptoms, including heat, redness, pain, itching and swelling. Wound-healing agents relieve these symptoms and provide long-lasting symptomatic relief by promoting tissue repair, reducing inflammation and encouraging wound healing. Recently, several U.S. Pat. Nos. 4,169,143; 4,192,866; 4,508,728 disclose compositions containing certain healing agents for treatment of hemorrhoids and other anorectal diseases.
It is also known that the presence of microorganisms such as fungi, bacteria, yeast and others delay healing and retard tissue repair. U.S. Pat. No. 4,518,583 discloses the use of compositions containing antimicrobial agents to treat anorectal diseases including hemorrhoids.
However, none of the above-cited treatments have been shown to be completely effective in satisfactory managing the symptoms of anorectal diseases including hemorrhoids, and in some cases the treatments themselves contribute to further problems such as causing allergies or additional tissue irritation.
It has been found that the entity known as chlorophyllin complex is more effective than the foregoing treatments for managing anorectal diseases including hemorrhoids while also lacking some of the undesirable side effects exhibited by some of the other treatments. The advantages of using chlorophyllin complex will be more apparent in the description of the invention which follows.
In the past, chlorophyllin copper complex has been disclosed for use in the treatment of ulcerative lesions, burns, wounds, especially with infected tissues, to promote their healing (U.S. Pat. Nos. 2,120,667; 2,729,586), in a poultry feed to prevent and control of duck disease (U.S. Pat. No. 2,646,384), as a body deodorant (U.S. Pat. No. 2,794,762), to improve alcoholic beverages' odor (Japanese Patent No. 81,106,586), for treatment of feces and urine of pets (Japanese Patent No. 85,120,926), to increase the stability of vitamin C (Japanese Patent No. 7743 ('57)) as a food dye to color gelatin capsules (Japanese Patent No. 80,161,863) and toothpastes (Japanese Patent No. 85,48,918). However, chlorophyllin copper complex is not disclosed in patents or other prior art for treatment of anorectal diseases including hemorrhoids. Chlorophyllin copper complex is safe and approved by the U.S. Food and Drug Administration for internal use as a deodorant (Federal Register, 50, 2516-7, 1985).